Why Is There Still No Female Viagra?

Viagra is practically synonymous with treatment of male erectile dysfunction, but men with ED can also choose from drugs such as Levitra, Stendra, and Cialis. Meanwhile, women suffering from sexual dysfunction can choose… nothing.

More than 17 years after Viagra received approval from the Food and Drug Administration (FDA), there still isn’t a drug on the market that can help women experiencing sexual dysfunction. One company, Sprout Pharmaceuticals, is hoping to change that with a sexual arousal drug for women called flibanserin, but the FDA has already rejected the medication twice.

Flibanserin is up for its third FDA review and will be the subject of a joint open public hearing held by the FDA this week, on June 4. During the approval process, the FDA weighs the potential risks versus benefits of a drug. So far, the agency has not found that the benefits of flibanserin outweigh the risks for women, which include sleepiness, drowsiness, and headaches.

Female sexual dysfunction is a term used to describe a persistent, recurring problem with sexual response or desirethat distresses a woman or strains her relationship with her partner, according to the Mayo Clinic. It includes vaginal dryness, difficulty reaching orgasm, a lack of libido, as well as distress related to the dysfunction. It can occur at any stage of a woman’s life and may be ongoing or sporadic.

Some women also have difficulty shutting off the multitasking part of their brain during sex, which can also cause sexual dysfunction, says Irwin Goldstein, MD, director of sexual medicine at Alvarado Hospital in San Diego and president-elect of the International Society for the Study of Women’s Sexual Health.

But while male sexual dysfunction has received a lot of attention in recent years, women experience it just as much as, if not more than, men. “Sexual dysfunction is actually more common in women than in men,” says Goldstein. He tells Yahoo Health that an estimated 43 percent of women will report experiencing sexual dysfunction at some point, compared with 31 percent of men.

Other companies have tried to create a drug for female sexual dysfunction and have failed, according to the New York Times, including a female version of Viagra, a testosterone skin patch for women, and a testosterone gel.

Online campaigns including #WomenDeserve and Even the Score have been fighting to get FDA approval for a “female Viagra,” and so far they haven’t been successful. But even the fight for a female sexual dysfunction drug is a little contentious among proponents of the idea. A Los Angeles Times op-ed published last year pointed out that both online campaigns were founded by Sprout Pharmaceuticals.

Women’s sexual health experts also seem to be divided on flibanserin itself. In a press release given to Yahoo Health, a coalition of women’s organizations including the National Women’s Health Network and the Seattle Institute for Sex Therapy, Education, and Research says flibanserin has “weak effectiveness relative to placebo” and an “unacceptable safety profile.”

But Holly Thacker, MD, director of the Cleveland Clinic’s Center for Specialized Women’s Health, points out that the potential side effects of flibanserin pale in comparison to the side effects of many erectile dysfunction drugs, which include the risk of heart attack, stroke, and vision and hearing loss.

“I think the FDA is acting very paternalistic about this drug,” Thacker tells Yahoo Health. “There are sexual dysfunction drugs that can cause serious side effects and even death for men. And flibanserin, which can just cause headache or nausea for women, has not been approved yet. They’re being a little too outright sexist.”

Drugs that have been created to fix a curvature of the penis can also lead to penile fracture, says Goldstein, but the FDA decided that the benefit (the ability for a man to have intercourse without pain) was greater than the risks.

Goldstein, who typically sees more women than men suffering from sexual dysfunction in his practice, says women experience the same consequences from sexual dysfunction as men — pain, embarrassment, the inability to orgasm, and issues with relationships, among other problems — but he argues that the FDA does not view the consequences as the same for men and women.

“There’s an amazing gender bias,” says Goldstein.

Currently, women experiencing sexual dysfunction have a few options. They can undergo psychological therapy, apply estrogen creams for vaginal dryness, or use battery-operated devices to stimulate their pelvic floor, causing an orgasm. “That’s pretty much it,” says Thacker.

While she says these treatments can be effective for some women, she notes that there is a group of women who biologically lose their sexual desire — women who could benefit from a pill like flibanserin.

“I hope that the FDA really takes a good look at this and approves it,” says Thacker. “I don’t see any indicators of this being a dangerous medication. Women should have that option.”

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